ALBUTEROL SULFATE - Generic Drug Details

What are the generic sources for albuterol sulfate and what is the scope of patent protection?

Albuterol sulfate is the generic ingredient in seventeen branded drugs marketed by Armstrong Pharms, Cipla, Lupin, Padagis Us, Sandoz, Teva Branded Pharm, Kindeva, Glaxosmithkline, Norvium Bioscience, Actavis Mid Atlantic, Apotex Inc, Bausch, Copley Pharm, Epic Pharma Llc, Landela Pharm, Lexenpharm, Luoxin Aurovitas, Nephron, Ritedose Corp, Roxane, Sentiss, Sun Pharm, Teva Pharms, Watson Labs, Watson Labs Inc, Wockhardt Eu Operatn, Schering, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Hikma, Mova, Quagen, Teva, Rising, Muro, Strides Pharma, Aizant, Am Therap, Amneal Pharms Co, Aurobindo Pharma Ltd, Dash Pharms Natco, Hibrow Hlthcare, Pliva, Sun Pharm Industries, Ucb Inc, Virtus Pharm, Warner Chilcott, Zydus Pharms, Astrazeneca, Boehringer Ingelheim, Aiping Pharm Inc, and Watson Labs Teva, and is included in one hundred and two NDAs. There are thirty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate has three hundred and sixty-three patent family members in twenty-nine countries.

There are eleven drug master file entries for albuterol sulfate. Forty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE

International Patents:	363
US Patents:	35
Tradenames:	17
Applicants:	54
NDAs:	102
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	46
Patent Applications:	6,250
Drug Prices:	Drug price trends for ALBUTEROL SULFATE
Drug Sales Revenues:	Drug sales revenues for ALBUTEROL SULFATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE
What excipients (inactive ingredients) are in ALBUTEROL SULFATE?	ALBUTEROL SULFATE excipients list
DailyMed Link:	ALBUTEROL SULFATE at DailyMed

See drug prices for ALBUTEROL SULFATE

See drug sales revenues for ALBUTEROL SULFATE

Recent Clinical Trials for ALBUTEROL SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bond Avillion 2 Development LP	Phase 3
Parexel	Phase 3
Aurobindo Pharma Ltd	Phase 3

See all ALBUTEROL SULFATE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROVENTIL-HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	020503	1	2015-05-20
PROAIR HFA	Inhalation Aerosol	albuterol sulfate	0.09 mg base per actuation	021457	1	2012-05-18
ACCUNEB	Inhalation Solution	albuterol sulfate	0.021%	020949	1	2005-10-19
ACCUNEB	Inhalation Solution	albuterol sulfate	0.042%	020949	1	2004-04-06

US Patents and Regulatory Information for ALBUTEROL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072860-002	Dec 20, 1989		DISCN	No	No
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	AB1	RX	Yes	Yes
Warner Chilcott	ALBUTEROL SULFATE	albuterol sulfate	TABLET;ORAL	072817-001	Jan 9, 1990		DISCN	No	No
Muro	VOLMAX	albuterol sulfate	TABLET, EXTENDED RELEASE;ORAL	019604-001	Dec 23, 1992		DISCN	Yes	No
Hikma	ALBUTEROL SULFATE	albuterol sulfate	SYRUP;ORAL	074749-001	Jan 30, 1998		DISCN	No	No
Ritedose Corp	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	214531-001	Dec 28, 2021	AN	RX	No	Yes
Luoxin Aurovitas	ALBUTEROL SULFATE	albuterol sulfate	SOLUTION;INHALATION	206224-001	Oct 17, 2017	AN	RX	No	No

Expired US Patents for ALBUTEROL SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	5,775,321
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	7,832,351*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,938,796*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,161,724*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,966,467*PED
Schering	PROVENTIL	albuterol sulfate	SOLUTION;INHALATION	019243-001	Jan 14, 1987	3,644,353
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,701,917

International Patents for ALBUTEROL SULFATE

Country	Patent Number	Title	Estimated Expiration
Israel	273158	התקן מתן תרופה עם אלקטרוניקה (Drug delivery device with electronics)
Canada	2958849	MODULE D'ASSISTANCE A LA CONFORMITE POUR UN INHALATEUR (COMPLIANCE-ASSISTING MODULE FOR AN INHALER)
World Intellectual Property Organization (WIPO)	2016033419
Canada	3043965	DISPOSITIF D'ADMINISTRATION DE MEDICAMENT COMPRENANT UNE ELECTRONIQUE (DRUG DELIVERY DEVICE WITH ELECTRONICS)
South Korea	20160066563
World Intellectual Property Organization (WIPO)	2016030521
Slovenia	2514467

ALBUTEROL SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Albuterol Sulfate

Introduction to Albuterol Sulfate

Albuterol sulfate, a short-acting beta agonist, is a widely used medication for managing respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Its efficacy in preventing and treating symptoms like wheezing, difficulty breathing, and coughing has made it a cornerstone in respiratory care.

Market Size and Growth Projections

The global albuterol sulfate market is poised for significant growth over the next few years. Here are some key projections:

• The market was valued at USD 5.22 billion in 2023 and is expected to reach USD 9.14 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.32% during the forecast period[1].
• Another report indicates that the market size was valued at USD 2.38 billion in 2023 and is expected to reach USD 4.07 billion by 2031, growing at a CAGR of 7.1% from 2024 to 2031[3].

Key Drivers of Market Growth

Several factors are driving the growth of the albuterol sulfate market:

Increasing Prevalence of Respiratory Diseases

The rising incidence of respiratory disorders such as asthma, COPD, and bronchitis is a major driver. These conditions are becoming more prevalent due to factors like air pollution, urbanization, and lifestyle changes[4].

Advancements in Inhalation Therapy

Innovations in inhaler technology, including metered-dose and dry powder inhalers, are expanding treatment options and improving patient compliance. Regulatory approvals for generic formulations also contribute to market growth[3].

Growing Awareness and Diagnosis

Improved awareness and diagnostic techniques have led to earlier detection and better management of respiratory conditions. This increased diagnosis rate translates into higher demand for albuterol sulfate[4].

Lifestyle Changes

Modern lifestyles, characterized by sedentary habits, poor dietary choices, and exposure to environmental pollutants, contribute to the development and exacerbation of respiratory diseases. Albuterol plays a crucial role in managing these lifestyle-related disorders[4].

Government Initiatives and Healthcare Expenditure

Governments and healthcare organizations are investing in awareness campaigns, research, and healthcare infrastructure to manage respiratory diseases. These initiatives increase access to albuterol medications, driving market growth[4].

Regional Market Dynamics

North America

North America dominates the albuterol sulfate inhalation aerosol market, accounting for 40% of the global market share. This dominance is attributed to the region's robust healthcare infrastructure, high prevalence of respiratory disorders, and strategic advancements in pharmaceutical development[1].

Financial Impact and Cost Savings

Formulary Substitutions

Studies have shown that formulary substitutions can lead to significant cost savings. For instance, substituting ipratropium-albuterol nebulization solution for metered-dose inhalers (MDIs) resulted in a three-month savings of $99,359 in drug costs and an extrapolated full-year savings of $397,436. Despite additional costs for equipment and personnel, the overall savings were substantial[2].

Cost Variability

The cost of albuterol sulfate can vary significantly based on factors such as insurance coverage, treatment plan, and the pharmacy used. Generic forms of albuterol tend to be less expensive than brand-name versions, and strategies like obtaining a 90-day supply can help reduce long-term costs[5].

Market Opportunities

Combination Therapies

Combination therapies that include albuterol along with other respiratory medications offer significant opportunities for market growth. These therapies provide enhanced efficacy and convenience, simplifying treatment regimens for patients[4].

Innovations in Delivery Systems

Ongoing research into new formulations and delivery systems, such as vibrating mesh nebulizers, is expected to further advance the market. Patient education programs and healthcare reforms promoting respiratory health awareness also support market expansion[3].

Challenges and Considerations

Regulatory Framework

The market is influenced by regulatory approvals and healthcare policies. Changes in these areas can impact the availability and affordability of albuterol sulfate medications[4].

Patient Compliance

Ensuring patient compliance with treatment regimens is crucial. Innovations in inhaler technology and patient education programs can help improve compliance rates[3].

Key Takeaways

• The albuterol sulfate market is expected to grow significantly, driven by increasing respiratory disease prevalence, advancements in inhalation therapy, and government initiatives.
• North America is the largest market due to its robust healthcare infrastructure and high prevalence of respiratory disorders.
• Formulary substitutions and the use of generic formulations can lead to substantial cost savings.
• Combination therapies and innovations in delivery systems offer opportunities for market growth.
• Patient compliance and regulatory frameworks are critical factors influencing market dynamics.

FAQs

Q: What is the projected growth rate of the albuterol sulfate market? A: The market is expected to grow at a CAGR of 8.32% from 2023 to 2030, according to some reports, and at a CAGR of 7.1% from 2024 to 2031, according to others[1][3].

Q: Which region dominates the albuterol sulfate inhalation aerosol market? A: North America dominates the market, accounting for 40% of the global market share due to its robust healthcare infrastructure and high prevalence of respiratory disorders[1].

Q: How can formulary substitutions impact costs? A: Formulary substitutions, such as switching from MDIs to nebulization solutions, can result in significant cost savings, despite additional costs for equipment and personnel[2].

Q: What factors influence the cost of albuterol sulfate? A: The cost can vary based on insurance coverage, treatment plan, pharmacy used, and whether the medication is in brand-name or generic form[5].

Q: What are some opportunities for market growth in the albuterol sulfate sector? A: Opportunities include combination therapies, innovations in delivery systems, and patient education programs that promote respiratory health awareness[3][4].

Sources

1. Exactitude Consultancy, "Albuterol Sulfate Inhalation Aerosol Market Trend Shows Outstanding Growth at a CAGR of 8.32% by 2030," EIN Presswire, April 2, 2024.
2. American Society of Health-System Pharmacists, Inc., "Financial effect of converting ipratropium-albuterol therapy from metered-dose inhalers to nebulization solution," PubMed, February 1, 2016.
3. Market Research Intellect, "Global Albuterol Sulfate Inhalation Aerosol Market Size and Projections," Market Research Intellect.
4. Data Bridge Market Research, "Global Albuterol Market – Industry Trends and Forecast to 2030," Data Bridge Market Research.
5. Medical News Today, "Albuterol cost 2024: Coupons and more," Medical News Today, May 25, 2021.